Preoperative Magnetic Tracking in Breast Surgery in France: French Medical-economic Study.

Not yet recruiting

• Conditions: Breast Cancer; Medico-economic Impact; Breast Cancer Surgery

• Registration Number: NCT06906601
• Lead Sponsor: Centre Leon Berard

Brief Summary

MAGNETO is a French medico-economic study on preoperative localization in breast cancer surgery. The main objective is to conduct a cost-consequence analysis comparing magnetic clip localization with the use of metallic wires for the preoperative identification of non-palpable breast lesions. The choice of localization method is left to the physician's and center's discretion. The study is non-interventional (with only questionnaires and data collection), prospective, and multicenter, with patient follow-up lasting up to six months after breast surgery.

Detailed Description

The MAGNETO study is a non-interventional, prospective, and multicenter study. It includes two cohorts: one using magnetic clip localization and the other using metallic wire localization.

Patients are enrolled by the surgeon during the preoperative consultation validating the conservative surgery with preoperative localization. The choice of cohort is left to the discretion of the center based on their routine practice. Baseline data, including patient and disease characteristics, are collected.

Depending on the assigned cohort, localization is performed either with a magnetic clip or a metallic wire. A mammogram is then performed to assess the correct positioning of the marker and its distance from the target lesion. At this stage, the radiologist completes a Likert scale satisfaction questionnaire.

Breast-conserving surgery is performed according to the hospital's standard practices. On the day of the procedure, the surgeon also completes a Likert scale satisfaction questionnaire.

Patients complete quality of life (EQ-5D-5L) and satisfaction questionnaires at several points throughout the study. Postoperative complications are also recorded.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-02
• Last Update Posted: 2025-04-02
• Study Start: 2025-04-15
• Primary Completion: 2026-04-15
• Study Completion: 2026-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 772

Inclusion Criteria

• I1. Female aged ≥ 18 years;
• I2. Patient presenting with a unifocal and unilateral lesion of invasive carcinoma or in situ;
• I3. Indication for first breast-conserving treatment with the need for preoperative localization of the lesion, regardless of the associated lymph node procedure;
• I4. Patient affiliated with a health insurance system;
• I5. Non-opposition to the study.

Exclusion Criteria

• E.1. Psychological, family, or sociological condition that may potentially compromise adherence to the treatment protocol and follow-up;
• E.2. Bilateral surgery required;
• E.3. Patient with metastatic breast cancer;
• E.4. Multifocal or benign lesions;
• E.5. Pregnant or breastfeeding patient;
• E.6. Need for neoadjuvant treatment;
• E.7. Associated breast reduction procedure;
• E.8. Patient under guardianship, curatorship, or deprived of liberty.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the average total cost of patient care with magnetic clip localization versus the use of a hookwire, up to 6 months post-surgery	6 months post surgery	Effectiveness of localization in terms of lesion identification (did the localization, based on the pathological report, allow the lesion to be located in the breast?); * Rate of clear margins (for isolated in situ lesions: margin ≥ 2 mm, and for invasive cancers: non-zero margin); * Percentage of patients requiring re-intervention due to an unclear margin; * Measured distance between the marker and the target lesion during the procedure; * Ratio between the weight of the resected specimen and the lesion size in g/mm²; * Patient satisfaction with their care, assessed using a 5-point Likert scale during the postoperative consultation (between day 15 and day 30 after resection); * Radiologist satisfaction with the marker placement, assessed using a 5-point Likert scale immediately after placement; * Surgeon satisfaction with lesion localization, assessed using a 5-point Likert scale at the end of the surgery.

Secondary Outcome Measures

Name	Time	Method
Quality of life of patientes	At inclusion, 15 to 30 days after surgery and 6 months after surgery	Quality of life assessed using the 5-level EQ-5D version (EQ-5D-5L).The questionnaire assesses 5 dimensions (Mobility, Self-care, Usual activities, Pain/Discomfort, Anxiety/Depression). Each dimension is rated on 5 levels (from 1 = no problems to 5 = extreme problems).
Budget impact analysis of pre operative magnetic clip localization versus the use of a hookwire.	At 1, 2 and 3 years	The decision to include a Budget Impact Analysis (BIA) in this study is in line with the framework agreement signed in January 2016 between the Economic Committee for Medicinal Products (Comité Economique des Produits de Santé - CEPS, in French) and the Pharmaceutical Industry (Les Entreprises du Médicament - LEEM, in French), which advises the implementation of a BIA in addition to the medico-economic study. The BIA will strictly comply with the HAS requirements presented in its methodological guide for BIA.; A budget impact model (BIM) will be developed with the French National health insurance perspective. The cost of the current (hookwire) or new intervention (magnetic clip) mix will be assessed. The population to be included in a BIA will be all patients eligible in France for the new intervention during the time horizon of 3 years. The results will be expressed in incremental budget impact in the first, second and third year.
Satisfaction of radiologist and surgeon	Within 24 hours after the maker placement and within 24 hours after the surgery	Questionnaire to evaluate the satisfaction of radiologist after the maker placement and questionnaire to evaluate the satisfaction of surgeon after the surgery. The score isn't on a scale.
Patient satisfaction and experience.	15 to 30 days after surgery	Questionnaire after the surgery to evaluated the patient satisfaction and experience. The score isn't on a scale.
The organisationnal impact of magnetic clip versus metallic wires.	At 6 months	The organizational analysis will be based on performance indicators of magnetic clips compared to metallic wires, such as the number of patient visits to the hospital before surgery, the number of localization procedures performed on the day of the intervention, the length of stay, waiting times, and the number of emergency visits throughout the follow-up period. The stochastic variables (lengths of stay, intervals between stays) will be modeled using appropriate statistical distributions, determined by maximum likelihood estimation based on statistical analyses of the extracted data.

Trial Locations

Locations (8)

Hospices Civils de Lyon Hopital de la Croix rousse; 🇫🇷 Lyon, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut de Cancérologie de l'Ouest Rene Gauducheau; 🇫🇷 Saint-Herblain, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Institut de Cancérologie de Lorraine (ICL); 🇫🇷 Nancy, France

Hôpital Nord -Ouest Val d'Oise (NOVO); 🇫🇷 Pontoise, France

Institut GODINOT; 🇫🇷 Reims, France

IUCT-Toulouse; 🇫🇷 Toulouse, France